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Completed

NCT Number: NCT01545843

Repeated Partial Sleep Deprivation to Augment SSRI Response in Depression

The purpose of the study is to determine whether changing sleep patterns improves response to an antidepressant medication.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

Depression is common and associated with social and economic costs. Although antidepressant medications are an effective treatment for depression, it can take as long as 6-8 weeks before symptoms improve, and 20-35% of individuals who use antidepressants still experience depression symptoms.

New treatments that accelerate response to antidepressants are important to reduce the burden of depression. The objectives of the proposed study are (1) to evaluate the effects of partial sleep deprivation compared to no sleep deprivation for improving response to 8 weeks of fluoxetine 20-40 mg treatment and (2) to examine the underlying sleep mechanisms of treatment response.

Participants who are eligible for the study will be randomly assigned to one of three sleep schedules for a 2-week period while taking fluoxetine: no sleep deprivation (8 hours time in bed), late bedtime (6 hours time in bed, with 2 hour bedtime delay) or early risetime (6 hours time in bed, with 2 hour advancement of rise time). Participants will spend a total of 7 nights in our sleep laboratory and will be followed on fluoxetine for an 8-week period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between 18 and 65 years old
  • Current major depressive episode
  • Habitual TIB of 7 to < 10 hours
  • No antidepressant medications for ≥ 2 weeks (4 weeks for MAOIs or longer acting antidepressants)
  • Score of at least 18 on the Hamilton Rating Scale of Depression

Exclusion criteria

  • Alcohol or substance abuse/dependence in past 6 months
  • Current posttraumatic stress disorder or bulimia nervosa (past 6 months)
  • Lifetime history of bipolar I or II disorder, schizophrenia/other psychotic disorder, and anorexia nervosa
  • Trials of fluoxetine in the past 6 months
  • Medical disorders or pain syndromes that may affect sleep or are associated with significant depression (e.g. thyroid or Cushing's disease); history of head trauma with loss of consciousness of > 5 minutes; history of seizures
  • Sleep disorders other than insomnia, such as sleep apnea and periodic limb movement disorder
  • Current use of prescription, over-the-counter, or naturopathic remedies for sleep (e.g., barbiturates, benzodiazepine agonists, nonbenzodiazepine hypnotics, analgesics) or depression (e.g., Sam-E, St. John's Wort)
  • Currently working evening or midnight shift (subjects who have recently traveled across multiple time zones will be included at the discretion of the PI).
  • Currently at risk for drowsy driving or employment that requires routine operation of transportation vehicles (e.g., truck/taxi driver, airline pilot) or hazardous equipment.
  • Known allergy, hypersensitivity or contraindication to study medication
  • Females: pregnant or nursing

Treatment and study plan

Sleep scheduling

Behavioral

8 hours vs. 6 hours time in bed for two weeks, with either 2 hour advance of risetime, or 2 hour delay of bedtime

Fluoxetine

Drug

20-40 mg fluoxetine daily for 8 weeks

Other names: Prozac

Primary outcomes

  1. Hamilton Rating Scale for Depression-17 Item Minus Sleep Items

    Time frame: Post-treatment (8 weeks)

    Total score on a clinician-rated measure of depressive symptoms, minus 3 sleep items Total score range: 0-46. Higher scores represent more severe depression.

Secondary outcomes

  1. Quick Inventory of Depressive Symptoms (QIDS)

    Time frame: Post-treatment (8 weeks)

    Patient-reported depression symptom severity at post-treatment, total score. Total scores range from 0 to 27. Higher scores represent more severe depression.

  2. Pittsburgh Sleep Quality Index

    Time frame: Baseline, 2 weeks and 8 weeks post-treatment

    Self-report measure of sleep quality. The Pittsburgh Sleep Quality Index is a validated scale which measures self-reported sleep quality based on a wide variety of questions (duration, quality, disturbances, medication, etc.) and converts them to a scale which ranges from 0 to 21 where 6 or higher denotes poor sleep quality.

  3. Change in EEG Sleep Measures I: Total Sleep Time

    Time frame: Baseline, 2 weeks, 8 weeks

    Measurement of EEG activity during sleep using polysomnography: Total Sleep Time is the length of time from sleep onset to final wake up minus any wakefulness during the night. It reflects the total amount of time asleep during the night.

  4. Change in EEG Sleep Measures II (Sleep Efficiency)

    Time frame: Baseline, 2 weeks, 8 weeks

    Measurement of EEG activity during sleep using polysomnography: Sleep efficiency [(total sleep time/time in bed)*100]

  5. Change in Neuropsychological Functioning: Memory

    Time frame: Baseline, 2 weeks, 8 weeks

    Change in different aspects of thinking (e.g., memory, attention, executive functioning)

  6. Change in Neurologic Functioning: Reaction Time

    Time frame: 0, 2, 8 weeks

    Reaction Time is measured using a modified Go/No-go test of inhibitory control

  7. Neurological Function (Emotional Perception)

    Time frame: 0 weeks, 2 weeks, 8 weeks

    Emotional Perception is measured based on the percent of faces whose emotions are correctly identified using the Facial Emotion Perception Test (FEPT)

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Mar 7, 2012
Registry last updated
Jan 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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